E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Asthma (an illness that causes breathing difficulty) that is not fully controlled, so that episodes of breathing difficulty are still occuring despite the use of other available treatments |
Asma (una enf. que causa dificultad respiratoria) que no se controla totalmente, de modo q los episodios de dificultad resp. se siguen produciendo a pesar de la utilización de otros ttos. disponibles |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10003553 |
E.1.2 | Term | Asthma |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the safety and tolerability of 2 dosing regimens of benralizumab for adult patients |
Evaluar la seguridad y la tolerabilidad de 2 pautas posológicas de benralizumab en pacientes adultos |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the effect of 2 dosing regimens of benralizumab on asthma exacerbations, and asthma-related hospitalizations and emergency room visits - To evaluate the pharmacodynamics and immunogenicity of 2 dosing regimens of benralizumab for adult patients |
- Evaluar el efecto de 2 pautas posológicas de benralizumab sobre las exacerbaciones del asma, así como las hospitalizaciones y visitas a urgencias relacionadas con el asma - Evaluar la farmacodinámica y la inmunogenia de 2 pautas de tratamiento de benralizumab en los pacientes adultos |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable European Union guidelines. 2.Female and male patients who have completed at least 16 and not more than 40 weeks in Study D3250C00021. 3.Women of childbearing potential (WOCBP) must agree to use an effective form of birth control throughout the study duration and for 16 weeks after the last dose of IP. 4.For WOCBP only: Have a negative urine pregnancy test prior to administration of IP at Visit 1. 5.All male patients who are sexually active must agree to use a double barrier method of contraception (condom with spermicide) from the first dose of IP until 16 weeks after their last dose. |
1. Se debe obtener el consentimiento informado para la participación en el ensayo antes de que se realice ningún procedimiento relacionado con el ensayo y según las directrices internacionales y/o las directrices aplicables de la Unión Europea. 2. Pacientes mujeres y varones que hayan completado al menos 16 y no más de 40 semanas en el ensayo D3250C00021. 3. Las mujeres en edad fértil (MEF) deben aceptar el uso de un método anticonceptivo eficaz a lo largo de todo el ensayo y durante 16 semanas tras la última dosis de PEI. 4. Solo para MEF: Deben hacerse una prueba de embarazo en orina antes de la administración de PEI en la vista 1. 5. Todos los pacientes varones que sean sexualmente activos deben acceder a usar un método anticonceptivo de doble barrera (preservativo con espermicida) desde la primera dosis de PEI hasta 16 semanas tras la última dosis. |
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E.4 | Principal exclusion criteria |
1. Any disorder including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric or major physical impairment that is not stable in the opinion of the Investigator and could:Affect the safety of the patient throughout the study; Influence the findings of the study or their interpretations; Impede the patient?s ability to complete the entire duration of study. 2. A helminth parasitic infection diagnosed during a predecessor study that has either required hospitalization, has not been treated, has been incompletely treated or has failed to respond to standard of care therapy. 3. Any clinically significant change in physical examination, vital signs, ECG, hematology, clinical chemistry, or urinalysis during the predecessor study which in the opinion of the investigator may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or interfere with the patient?s ability to complete the entire duration of the study. 4. Current malignancy or malignancy that developed during the predecessor study (subjects that had basal cell carcinoma, localized squamous cell carcinoma of the skin which was resected for cure, or in situ carcinoma of the cervix that has been treated/cured will not be excluded). 5.Receipt of live attenuated vaccines within 30 days prior to initiation of treatment in this study, during the treatment period, and for 16 weeks (5 half-lives) after the last dose of the IP. 6. Receipt of immunoglobulin or blood products within 30 days prior to Visit 1. 7. Planned major surgical procedures during the conduct of the study. 8. Previous participation in the present study. 9. Concurrent enrolment in another drug-related interventional clinical trial. 10. AstraZeneca staff involved in the planning and/or conduct of the study. 11. Employees of the study center or any other individuals involved with the conduct of the study or immediate family members of such individuals. 12. Patients with important protocol deviations in the predecessor study at the discretion of the Sponsor. 13. Patients with ongoing serious adverse events (SAEs) from the prior study should not be enrolled into the this extension study until the SAE has resolved (see Section 7.1.3.1) |
1. Cualquier trastorno, incluidos entre otros cardiovascular, gastrointestinal, hepático, renal, neurológico, musculoesq., infeccioso, endocrino, metabólico, hematológico, psiquiátrico o impedimento físico importante que no sea estable en opinión del invest. y que podría: Afectar la seguridad del paciente a lo largo del ensayo. Influir en los hallazgos del ensayo o en sus interpretaciones. Impedir la capacidad del pac. para completar la duración total del ensayo. 2. Una infección parasitaria por helmintos diagnosticada durante un ensayo precedente que ha necesitado hospitaliz., no ha sido tratada, se ha tratado de forma incompleta o no ha respondido al tto. estándar. 3. Cualq. cambio clínicam. significativo en la exploración física, constantes vitales, ECG, hematología, bioquímica clínica o análisis de orina durante el ensayo precedente que, en opinión del investigador, pueda poner en riesgo al paciente por su participación en el ensayo, pueda influir en los resultados del ensayo o interferir en la capacidad del paciente para completar el ensayo en su totalidad. 4. Neoplasia maligna actual o neoplasia maligna que se desarrollara durante el ensayo precedente (no se excluirá a los sujetos que tuvieron carcinoma basocelular, carcinoma espinocelular localizado de la piel que se extirpó para su curación o carcinoma in situ del cuello uterino que ha sido tratado/curado). 5. Ser receptor de vacunas atenuadas vivas en el plazo de los 30 días antes de iniciar el tratamiento de este ensayo, durante el periodo de tratamiento y durante 16 semanas (5 semividas) después de la última dosis de PEI. 6. Ser receptor de inmunoglobulina o hemoderivados en los 30 días previos a la visita 1. 7. Tener planificadas intervenciones quirúrgicas importantes durante la realización del ensayo. 8. Participación anterior en el ensayo actual. 9. Inclusión concurrente en otro ensayo clínico intervencional relacionado con un fármaco. 10. Personal de AstraZeneca implicado en la planificación y/o realización del ensayo. 11. Empleados del centro del ensayo u otras personas implicadas en la realización del ensayo o miembros de la familia inmediata de dichas personas. 12. Pacientes con desviaciones del protocolo importantes en el ensayo precedente, a discreción del promotor. 13. Los pacientes con acontecimientos adversos serios (AAG) continuados del primer ensayo no deben incluirse en este ensayo de extensión hasta que el AAG se haya resuelto (consulte la sección 7.1.3.1). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of Adverse Events/Serious Adverse Events (AEs/SAEs) |
Número de Acontecimentos Adversos/Acontecimiento Adverso Grave (AA/AAG) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
around 108 weeks, around 108 weeks, duration will differ based on time of local BLA approval |
Alrededor de 108 semanas, la duración será diferente en función del tiempo de aprobación local BLA |
|
E.5.2 | Secondary end point(s) |
- Asthma exacerbations - Asthma-related hospitalizations and emergency room visits. - Eosinophil levels - Anti-drug antibodies (ADA) |
- Exacerbaciones del asma - Hospitalizaciones y visitas a urgencias relacionadas con el asma - Niveles de eosinófilos - Anticuerpos contra el fármaco (ADA) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
around 108 weeks, around 108 weeks, duration will differ based on time of local BLA approval |
Alrededor de 108 semanas, la duración será diferente en función del tiempo de aprobación local BLA |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Tolerability |
Tolerabilidad |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Dos regímenes de dosificación |
two dosing regiments |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 97 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
Brazil |
Bulgaria |
Canada |
Chile |
Czech Republic |
France |
Germany |
Peru |
Philippines |
Poland |
Romania |
Russian Federation |
South Africa |
Spain |
Sweden |
Turkey |
Ukraine |
United Kingdom |
United States |
Vietnam |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LSLV |
Última visita del último paciente |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |